36-Item Short Form Survey (SF-36) Versus Gait Speed As Predictor of Preclinical Mobility Disability in Older Women: The Women's Health Initiative ...

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CLINICAL INVESTIGATION

36-Item Short Form Survey (SF-36) Versus Gait Speed As
Predictor of Preclinical Mobility Disability in Older Women:
The Women’s Health Initiative
Deepika R. Laddu, PhD,a Betsy C. Wertheim, MS,b David O. Garcia, PhD,c Nancy F. Woods,
PhD,d Michael J. LaMonte, PhD,e Bertha Chen, MD,f Hoda Anton-Culver, PhD,g Oleg Zaslavsky,
PhD,d Jane A. Cauley, DrPH,h Rowan Chlebowski, MD, PhD,i JoAnn E. Manson, MD, DrPH,j
Cynthia A. Thomson, PhD, RD,b,c and Marcia L. Stefanick, PhD,f,k for the Women’s Health
Initiative Investigators

                                                                               the predictive value of SF-36 PF with that of measured gait
OBJECTIVES: To compare the value of clinically mea-                            speed.
sured gait speed with that of the self-reported Medical                        RESULTS: Slower baseline gait speed and lower SF-36 PF
Outcomes Study 36-item Short-Form Survey Physical                              scores were associated with higher adjusted odds of PCMD
Function Index (SF-36 PF) in predicting future preclinical                     at Years 3 and 6 (all P < .001). For gait speed, decliners
mobility disability (PCMD) in older women.                                     were 2.59 times as likely to have developed PCMD as
DESIGN: Prospective cohort study.                                              nondecliners by Year 3 and 2.35 times as likely by Year 6.
SETTING: Forty clinical centers in the United States.                          Likewise, for SF-36, decliners were 1.42 times as likely to
PARTICIPANTS: Women aged 65 to 79 enrolled in the                              have developed PCMD by Year 3 and 1.49 times as likely
Women’s Health Initiative Clinical Trials with gait speed                      by Year 6. Baseline gait speed (AUC = 0.713) was non-
and SF-36 assessed at baseline (1993–1998) and follow-up                       significantly better than SF-36 (AUC = 0.705) at predicting
Years 1, 3, and 6 (N = 3,587).                                                 PCMD over 6 years (P = .21); including measures at a sec-
                                                                               ond time point significantly improved model discrimina-
MEASUREMENTS: Women were categorized as nonde-
                                                                               tion for predicting PCMD (all P < .001).
cliners or decliners based on changes (from baseline to
Year 1) in gait speed and SF-36 PF scores. Logistic regres-                    CONCLUSION: Gait speed identified PCMD risk in older
sion models were used to estimate incident PCMD (gait                          women better than the SF-36 PF did, although the results
speed
2     LADDU ET AL.                                                                                                  2018    JAGS

excellent interrater and test–retest reliability,2 sensitivity to   of comorbidities (diabetes mellitus, cardiovascular disease
change, and predictive validity.3–5 Slower gait speed               (CVD)) than those lost to follow-up. Likewise, women
(
JAGS     2018                                                         PREDICTING PRECLINICAL MOBILITY DISABILITY RISK       3

variables. Crude associations between baseline gait speed
                                                                Associations Between Baseline Gait Speed or SF-36 and
and SF-36 PF were measured using Pearson correlation.
                                                                PCMD
Associations between baseline measures of gait speed or
SF-36 PF scores and PCMD were tested using logistic             A 1-standard deviation (SD) (0.21 m/s) faster baseline gait
regression for each follow-up year separately, yielding         speed was associated with 47% lower odds of PCMD at
odds ratios (ORs) and 95% confidence intervals (CIs).           Year 3 and 35% lower odds at Year 6 (Table 2). Likewise,
Analyses were repeated using change in gait speed and           a 1-SD (17.5 points) higher baseline SF-36 score was asso-
SF-36 PF as predictors of incident PCMD between base-           ciated with 24% lower odds of new PCMD at Year 3 and
line and Year 3 and again for incident PCMD between             31% lower at Year 6 (all P < .001).
baseline and Year 6. We included as covariates any mea-
sures or characteristics present at baseline that might con-
                                                                Predicted New PCMD by Decliners vs Nondecliners
found the relationship between PF and PCMD. Thus,
three levels of covariate adjustment were applied: age,         For gait speed decliners, the overall cumulative incidence
clinical trial arm(s), and baseline gait speed; age at meno-    of PCMD ( .5 ).
decliners than nondecliners (P < .05). Additionally, base-
line gait speeds were higher in gait speed decliners than
                                                                DISCUSSION
nondecliners, whereas gait speed nondecliners reported
higher SF-36 scores than decliners at baseline (both            The results of this large, prospective study demonstrate
P < .05).                                                       that gait speed is somewhat more strongly associated than
     Furthermore, 22% of women in this study sample             SF-36 PF with PCMD risk after 3 and 6 years in ambula-
were categorized as SF-36 PF decliners, having Year 1 SF-       tory, community-dwelling women aged 65 and older, sup-
36 PF scores 10 points or more lower than at baseline           porting its practical application in clinical settings and
(Table 1). Significant differences in age, age at onset of      healthcare research. Nevertheless, the similar predictive
menopause, education, alcohol use, physical activity levels,    ability and discrimination of PCMD using these two met-
and anthropometrics were observed in SF-36 PF decliners         rics suggests that the SF-36 PF is an appropriate, easily
but not in nondecliners. SF-36 PF decliners had signifi-        obtained surrogate for clinically measured gait speed in
cantly slower gait speeds and a higher prevalence of some       screening older women for declining PF and increasing sus-
chronic diseases than nondecliners (all P < .05).               ceptibility to mobility disability over time. Prediction of
4      LADDU ET AL.                                                                                                                        2018            JAGS

Table 1. Baseline Characteristics According to Change in Gait Speed and 36-Item Short-Form Physical Function
Index (SF-36 PF)
                                                                                      Gait speed                                      SF-36 PF

                                                      Total,             Nondecliner,            Decliner,            Nondecliner,               Decliner,
             Characteristic                         N = 3,587             n = 2,056              n = 1,531             n = 2,802                 n = 785

Gait speed, m/s, mean  SDa†,b‡                    1.25      0.2        1.19      0.2         1.34      0.2        1.26      0.2         1.24         0.2
SF-36 PF score, mean  SD a                        80.8      17.5       81.3      17.2        80.2      18.0       81.1      18.0        79.9         15.6
Age, mean  SD a†, b‡                              69.6      3.6        69.4      3.5         69.9      3.7        69.5      3.5         69.9         3.8
Age at menopause, years, mean  SD       a†
                                                   48.5      6.5        48.6      6.4         48.3      6.7        48.7      6.4         47.8         6.9
Race and ethnicity, n (%)a*
   Non-Hispanic white                              3198 (89.2)           1859 (90.3)            1342 (87.7)           2503 (89.3)                695 (88.5)
   Black                                            193 (5.38)            104 (5.1)               89 (5.8)             145 (5.2)                  48 (6.1)
   Other, unknown                                   196 (5.46)             96 (4.7)              100 (6.5)             154 (5.5)                  42 (5.4)
Education, n (%)b*
   ≤High school, vocational                        1285   (36.0)          736   (36.0)           549   (36.1)          974   (35.0)           311      (39.8)
   Some college, associate degree                  1042   (29.2)          580   (28.4)           462   (30.4)          835   (30.0)           207      (26.5)
   ≥College degree                                 1238   (34.7)          728   (35.6)           510   (33.5)          974   (35.0)           264      (33.8)
   BMI, kg/m2, meanSDb†                           27.9    5.3          27.9    5.5           27.9    5.1          27.6    5.2           29.0       5.7
   Physical activity, metabolic                    12.0    13.2         11.8    12.9          12.3    13.7         12.4    13.5          10.7       12.3
   equivalent h/wk, meanSDb‡
Self-reported general health, n (%)b,†
   Excellent                                        601   (16.8)          355   (17.3)           246   (16.1)          505   (18.1)               96   (12.2)
   Very good                                       1594   (44.5)          898   (43.7)           696   (45.6)         1285   (45.9)              309   (39.4)
   Good                                            1184   (33.0)          687   (33.4)           497   (32.5)          867   (31.0)              317   (40.4)
   Fair, poor                                       204   (5.7)           115   (5.6)             89   (5.8)           141   (5.0)                63   (8.0)
Depression (CES-D > 0.06)                           266   (7.6)           152   (7.5)            114   (7.57)          207   (7.5)                59   (7.7)
Alcohol useb‡
   Nondrinker                                       414   (11.6)          217   (10.6)           197   (12.9)          320   (11.5)               94   (12.1)
   Past drinker, n (%)                              648   (18.2)          373   (18.3)           275   (18.0)          474   (17.0)              174   (22.3)
JAGS                  2018                                                                         PREDICTING PRECLINICAL MOBILITY DISABILITY RISK                   5

future PCMD in the present study was significantly stron-                          in part, because gait speed was not only an explanatory
ger when considering measures from two time points than                            variable, but was also used to define PCMD.
from only one. Thus, our results emphasize the importance                               When evaluating future disability risk in older popula-
of monitoring functional status repeatedly over time to aid                        tions, the approach for selecting the most appropriate
clinicians in assessing an individual’s risk of mobility limi-                     functional measure remains unclear.2,9,10,13 In our study,
tations and to guide initiation and intensity of prevention                        gait speed alone (at baseline or 1-year change) usually per-
strategies that delay onset of disability in older adults.                         formed significantly better in predicting incident PCMD
     Gait speed and other measures of PF tend to decline                           than SF-36 PF, according to the AUC. These findings
with advancing age. As expected, 43% of the current study                          appear consistent with a previous study2 that recognized
sample experienced declines in gait speed of 0.1 m/s or                            gait speed as a “vital sign” for health-related risk of geri-
more, and 22% reported SF-36 PF scores of 10 points or                             atric conditions including “dysmobility” or gait disor-
more lower over 1 year. Furthermore, women identified as                           ders2,24, but in the present study, single baseline measures
gait speed or SF-36 decliners had a substantial likelihood                         of SF-36 PF and gait speed had comparable discrimination
of having developed PCMD by Years 3 and 6. In fully                                between women with and without PCMD (1–3% differ-
adjusted models, gait speed decliners had greater PCMD                             ence) over 6 years of follow-up, consistent with other
risk at each follow-up (Year 3: OR = 2.59; Year 6:                                 investigations,1,8 despite the fact that gait speed and SF-36
OR = 2.35) than SF-36 decliners (Year 3: OR = 1.42;                                PF do not measure the same construct of functional status
Year 6: OR = 1.49). Similar findings have been reported in                         and disability.9,13 Similar WHI studies have reported that
other epidemiological studies of older adults.2,7,23 The                           SF-36 performs as well as physical performance measures
greater odds of PCMD associated with slowing gait speed                            in defining frailty and predicting risk of falls, hip fracture,
than with decline in self-reported PF could be explained,                          and mortality.25

Table 2. Associations Between Baseline Gait Speed or 36-Item Short-Form Physical Function Index (SF-36 PF) and
Incident Preclinical Mobility Disability (
6             LADDU ET AL.                                                                                                         2018     JAGS

      1.00

                                                                                  1.00
      0.75      A                                                                           B

                                                                                  0.75
Sensitivity

                                                                            Sensitivity
  0.50

                                                                              0.50
      0.25

                                                                                  0.25
                                        Baseline ROC area: 0.7134                                               Baseline ROC area: 0.7049
                                        Baseline + Y1 ROC area: 0.7388                                          Baseline + Y1 ROC area: 0.7123
                                        Reference                                                               Reference
      0.00

                                                                                  0.00
              0.00       0.25      0.50             0.75             1.00                 0.00   0.25      0.50             0.75             1.00
                                1-Speci city                                                            1-Speci city

Figure 2. Receiver operating characteristic (ROC) curves for predicting new preclinical mobility disability at Year 6 according to
physical function measured at baseline only (gray) or baseline plus 1 year (black). Gait speed, test for difference in ROC curves;
P < .001. Medical Outcomes Study 36-Item Short-Form Physical Function Index, test for difference in ROC curves; P = .004.

      Discrimination of women with future PCMD from                         self-reported PF assessments at baseline and 1 year. Fur-
those without was nearly 5 percentage points greater for                    thermore, a 1 m/s cut-point to define new PCMD is based
1-year change in gait speed than SF-36 PF over 6 years.                     on previous studies that have validated its relevance to
Thus, our findings suggest that gait speed is a more appro-                 functional disability, morbidity, and survival in older
priate, more sensitive measure when quantifying risk of                     adults.6,7,21,22 Some studies have used slower cut-points
incident PCMD, an association that reported declines in                     (≤0.6 or 0.2). Hence, routine                   of future functional disability in individuals with preclini-
assessments of gait speed may provide greater value than                    cal disability. Our findings suggest that PCMD risk can be
the SF-36 PF for developing risk profiles underlying vari-                  identified in older women with faster gait speeds. To our
ous physiological processes (cardiopulmonary or neurolog-                   knowledge, a similar criterion for SF-36 PF score that
ical deficits) in nondisabled, healthy older populations and                reflects mobility disability has not been established. In our
for evaluating an individual’s trajectory from functional                   study, we standardized gait speed and SF-36 PF exposures
independence to disability over time.2,22,26 Regular moni-                  to the standard normal distribution (per 1 SD) to facilitate
toring of gait speed in older clinical populations may also                 more direct comparisons of associations with PCMD for
distinguish presence and severity of subtle functional                      each exposure. Alternative measures of subclinical mobility
changes in individuals who do not report functional prob-                   disability (e.g., difficulty walking a one-quarter of a mile,
lems and thus identify persons who may need and use                         climbing a flight of stairs, performance on a longer walk-
more healthcare services over time.2,27 The SF-36 PF                        ing test) were not available in this cohort. We also
appears to be a suitable alternative measure of gait speed                  acknowledge the possibility of selection bias, because
in clinical and epidemiological studies of older women if                   women who were excluded because they were missing
the primary question is to determine likelihood of future                   Year 1 SF-36 PF or gait speed data (19%) had significantly
PCMD. Likewise, the SF-36 PF may serve as proxy for                         slower gait speeds than those who were not missing Year
clinical gait speed testing if gait speed necessitates addi-                1 measures (data not shown). In addition, self-reported
tional costs (staff time) or imposes a burden on older                      SF-36 PF scores represent personal perspectives of health
adults with other health risks or fatigue.2 Nonetheless,                    that mood, expectations, or past experiences that were not
given that difficulties in mobility often precede other age-                included in adjusted analyses may influence differently in
associated adverse outcomes, including falls, hip fracture,                 different participants.
and hospitalization,9,28 the opportune time to intervene in
older women may be between baseline and the first year
                                                                            CONCLUSION
after an initial functional assessment, when the likelihood
of promoting recovery and prevent disability onset is high.                 One-year declines in clinically measured gait speed showed
The utility of baseline self-report and clinical PF and 1-year              greater sensitivity to change in mobility than SF-36 PF
changes in self-report and clinical PF in predicting future                 scores alone, although baseline SF-36 PF scores had perfor-
risk of established mobility disability, as well as other                   mance comparable with that of gait speed in discriminat-
health outcomes (all-cause and cause-specific mortality,                    ing future PCMD cases in older women. The present
falls, and hospitalization), will be examined in the WHI.                   findings may be limited given that gait speed was used as a
                                                                            primary predictor and to define the PCMD outcome.
                                                                            Nonetheless, clinically measured functional assessments,
STRENGTHS AND LIMITATIONS
                                                                            such as gait speed, may provide additional information
This study had several strengths, including the large,                      regarding the hypothesized mechanism of mobility disabil-
prospective study design and availability of clinical and                   ity (lower extremity muscle strength) and may thus aid in
JAGS      2018                                                                            PREDICTING PRECLINICAL MOBILITY DISABILITY RISK                        7

diagnosis and treatment in clinical settings. Nevertheless,                       7. Cesari M, Kritchevsky SB, Penninx BW et al. Prognostic value of usual gait
                                                                                     speed in well-functioning older people—results from the Health, Aging and
self-reported PF may be a more feasible and practical tool
                                                                                     Body Composition Study. J Am Geriatr Soc 2005;53:1675–1680.
for describing disability risk and prevention in older                            8. Fried LP, Tangen CM, Walston J et al. Frailty in older adults: Evidence for
women when gait speed is not available. The choice to use                            a phenotype. J Gerontol A Biol Sci Med Sci 2001;56A:M146–M156.
performance or self-reported measures in clinical and epi-                        9. Latham NK, Mehta V, Nguyen AM et al. Performance-based or self-report
                                                                                     measures of physical function: Which should be used in clinical trials of
demiological studies should be based on the study popula-
                                                                                     hip fracture patients? Arch Phys Med Rehabil 2008;89:2146–2155.
tion, feasibility, and research objectives.9 Additional                          10. Syddall HE, Martin HJ, Harwood RH et al. The SF-36: A simple, effective
considerations in healthcare settings should focus on ease                           measure of mobility-disability for epidemiological studies. J Nutr Health
and cost of administration in terms of equipment, space,                             Aging 2009;13:57–62.
                                                                                 11. Ferrucci L, Guralnik JM, Studenski S et al. Designing randomized, con-
time, patient characteristics, and patient burden (fatigue,
                                                                                     trolled trials aimed at preventing or delaying functional decline and disabil-
physical limitations or disabilities). Regardless of which                           ity in frail, older persons: A consensus report. J Am Geriatr Soc 2004;
measure is selected, using two time points, possibly a year                          52:625–634.
or more apart, to assess trajectories of change in mobility                      12. Singh JA, Borowsky SJ, Nugent S et al. Health-related quality of life, func-
                                                                                     tional impairment, and healthcare utilization by veterans: Veterans’ Quality
provides better clinical value than a single measure in
                                                                                     of Life Study. J Am Geriatr Soc 2005;53:108–113.
predicting future PCMD.                                                          13. Hoeymans N, Feskens EJ, van den Bos GA et al. Measuring functional sta-
                                                                                     tus: cross-sectional and longitudinal associations between performance and
                                                                                     self-report (Zutphen Elderly Study 1990–1993). J Clin Epidemiol
ACKNOWLEDGMENTS                                                                      1996;49:1103–1110.
                                                                                 14. Design of the Women’s Health Initiative clinical trial and observational
The authors thank the WHI investigators and staff for                                study. The Women’s Health Initiative Study Group. Control Clin Trials
their dedication and the study participants for making the                           1998;19:61–109.
program possible. A listing of WHI investigators can be                          15. Anderson GL, Manson J, Wallace R et al. Implementation of the Women’s
found at https://www.whi.org/researchers/Documents%                                  Health Initiative study design. Ann Epidemiol 2003;13(9 Suppl):S5–S17.
                                                                                 16. Guralnik JM, Ferrucci L, Simonsick EM et al. Lower-extremity function in
20%20Write%20a%20Paper/WHI%20Investigator%                                           persons over the age of 70 years as a predictor of subsequent disability. N
20Short%20List.pdf.                                                                  Engl J Med 1995;332:556–561.
     The research presented in this paper is that of the                         17. Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey
authors and does not reflect the official policy of the NIH                          (SF-36). I. Conceptual framework and item selection. Med Care 1992;30:
                                                                                     473–483.
or NHLBI.                                                                        18. Perera S, Mody SH, Woodman RC et al. Meaningful change and respon-
     Conflict of Interest: The authors declare no conflict of                        siveness in common physical performance measures in older adults. J Am
interest and have no financial disclosures to report.                                Geriatr Soc 2006;54:743–749.
     Financial Disclosure: The WHI program is funded by                          19. Studenski S. Current Geriatric Diagnosis and Treatment. In: Landefeld
                                                                                     CSPR, Johnson MA, et al., eds. Exercise. New York: McGraw-Hill, 2004,
the National Heart, Lung, and Blood Institute (NHLBI),                               pp. 436–446.
National Institutes of Health (NIH), U.S. Department of                          20. Perera S, Studenski S, Chandler JM et al. Magnitude and patterns of
Health and Human Services through contracts                                          decline in health and function in 1 year affect subsequent 5-year survival. J
N268201100046C, HHSN268201100001C, HHSN26820-                                        Gerontol A Biol Sci Med Sci 2005;60A:894–900.
                                                                                 21. Bohannon RW, Williams Andrews A. Normal walking speed: A descriptive
1100002C, HHSN268201100003C, HSN268201100004C,                                       meta-analysis. Physiotherapy 2011;97:182–189.
and HHSN271201100004C.                                                           22. Studenski S, Perera S, Patel K et al. Gait speed and survival in older adults.
     Author Contributions: DRL: Study concept and                                    JAMA 2011;305:50–58.
design, data analysis, interpretation of results, writing the                    23. Simonsick EM, Newman AB, Visser M et al. Mobility limitation in self-
                                                                                     described well-functioning older adults: Importance of endurance walk test-
manuscript. MLS, BCW, OZ, MJL: Consultation on                                       ing. J Gerontol A Biol Sci Med Sci 2008;63A:841–847.
methodology, analysis interpretation. BCW: Statistical data                      24. Mouton CP, Espino DV. Health screening in older women. Am Fam Physi-
analysis, interpretation of results. DOG, NFW, MLJ, BC,                              cian 1999;59:1835–1842.
HAC, MJL, BC, OZ, JAC, RC, JEM, CAT, MLS: Critical                               25. Zaslavsky O, Zelber-Sagi S, Gray SL et al. Comparison of frailty pheno-
                                                                                     types for prediction of mortality, incident falls, and hip fracture in older
revisions to manuscript.                                                             women. J Am Geriatr Soc 2016;64:1858–1862.
     Sponsor’s Role: None.                                                       26. Middleton A, Fritz SL, Lusardi M. Walking speed: The functional vital
                                                                                     sign. J Aging Phys Activity 2015;23:314–322.
                                                                                 27. Graham JE, Fisher SR, Berges IM et al. Walking speed threshold for classi-
REFERENCES                                                                           fying walking independence in hospitalized older adults. Phys Ther 2010;90:
                                                                                     1591–1597.
1. Fried LP, Bandeen-Roche K, Chaves PH et al. Preclinical mobility disability   28. Fried LP, Guralnik JM. Disability in older adults: Evidence regarding sig-
   predicts incident mobility disability in older women. J Gerontol A Biol Sci       nificance, etiology, and risk. J Am Geriatr Soc 1997;45:92–100.
   Med Sci 2000;55A:M43–M52.                                                     29. Abellan van Kan G, Rolland Y, Andrieu S et al. Gait speed at usual pace
2. Studenski S, Perera S, Wallace D et al. Physical performance measures in          as a predictor of adverse outcomes in community-dwelling older people an
   the clinical setting. J Am Geriatr Soc 2003;51:314–322.                           International Academy on Nutrition and Aging (IANA) Task Force. J Nutr
3. Onder G, Penninx BW, Lapuerta P et al. Change in physical performance             Health Aging 2009;13:881–889.
   over time in older women: The Women’s Health and Aging Study. J Geron-
   tol A Biol Sci Med Sci 2002;57A:M289–M293.
4. Rosso AL, Lee BK, Stefanick ML et al. Caregiving frequency and physical
   function: The Women’s Health Initiative. J Gerontol A Biol Sci Med Sci
                                                                                 SUPPORTING INFORMATION
   2015;70A:210–215.
5. Guralnik JM, Ferrucci L, Pieper CF et al. Lower extremity function and
                                                                                 Additional Supporting Information may be found in the
   subsequent disability: Consistency across studies, predictive models, and     online version of this article:
   value of gait speed alone compared with the Short Physical Performance
   Battery. J Gerontol A Biol Sci Med Sci 2000;55A:M221–M231.
                                                                                     Figure S1. Receiver operating characteristic (ROC)
6. Hardy SE, Perera S, Roumani YF et al. Improvement in usual gait speed
   predicts better survival in older adults. J Am Geriatr Soc 2007;55:1727–      curves for predicting new pre-clinical mobility disability
   1734.                                                                         according to gait speed (gray) or SF-36 (black) at baseline.
8    LADDU ET AL.                                                                                         2018    JAGS

A. Outcome at year 3, test for difference in ROC curves;   clinical mobility disability (
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